Table 1.
Patient demographics and baseline characteristics
| Tislelizumab (n = 256) | ICC (n = 256) | |
|---|---|---|
| Age, median (range), years | 62.0 (40-86) | 63.0 (35-81) |
| <65 years, n (%) | 157 (61.3) | 161 (62.9) |
| ≥65 years, n (%) | 99 (38.7) | 95 (37.1) |
| Sex, n (%) | ||
| Male | 217 (84.8) | 215 (84.0) |
| Female | 39 (15.2) | 41 (16.0) |
| Geographic region,an (%) | ||
| Asia | 201 (78.5) | 203 (79.3) |
| Europe/North America | 55 (21.5) | 53 (20.7) |
| ECOG performance status, n (%) | ||
| 0 | 66 (25.8) | 60 (23.4) |
| 1 | 190 (74.2) | 196 (76.6) |
| PD-L1 expression, n (%) | ||
| TAP ≥10% | 89 (34.8) | 68 (26.6) |
| TAP <10% | 116 (45.3) | 140 (54.7) |
| Unknown | 51 (19.9) | 48 (18.8) |
| Smoking status, n (%) | ||
| Never smoker | 68 (26.6) | 63 (24.6) |
| Current/former smoker | 188 (73.4) | 192 (75.0) |
| Missing | 0 (0.0) | 1 (0.4) |
| Previous therapies, n (%) | ||
| Surgery | 94 (36.7) | 99 (38.7) |
| Radiotherapy | 169 (66.0) | 163 (63.7) |
| Platinum-based chemotherapy | 249 (97.3) | 252 (98.4) |
| Disease stage at study entry, n (%) | ||
| Locally advanced | 5 (2.0) | 20 (7.8) |
| Metastatic | 251 (98.0) | 236 (92.2) |
ECOG, Eastern Cooperative Oncology Group; ICC, investigator-chosen chemotherapy; PD-L1, programmed death-ligand 1; TAP, tumor abnormal protein.
a
There were 50 patients from Japan: 25 patients in the tislelizumab arm and 25 patients in the chemotherapy arm.